FDA user fee bill heads to the White House | MassDevice.com On Call

MASSDEVICE ON CALL — The U.S. Senate last night voted 92-4 to approve the latest iteration of the Medical Device User Fee & Modernization Act, which was bundled in a larger FDA user fee measure.

Lawmakers agreed to push forward the bill, which will now head to the White House for a signature from President Barack Obama before becoming law.

Boston Scientific (NYSE:BSX) lauded the progress and promised to work closely with the FDA to ensure smooth implementation of some of the bill’s initiatives, which aim to make the FDA review process more predictable and efficient.

"This bill provides for the opportunity to accelerate the introduction of innovative medical devices without compromise to patient safety," Boston Scientific CEO Hank Kucheman said in prepared remarks. "We are hopeful that these reforms will have a strong and lasting impact on the FDA’s ability to address lengthening review times, spur innovation and promote faster patient access to new therapies."

At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.